MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Bacterial Infection (1735); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Itching Sensation (1943); Menstrual Irregularities (1959); Urinary Tract Infection (2120); Cramp(s) (2193)

Event Date 11/09/2017

Event Type  Injury  

Event Description

I had ongoing problems with essure including pelvic cramping, irregular bleeding, high increase in uti¿s and a number of kidney infections, bacterial vaginosis, hair loss, itching, general immune system compromisation, headaches, seborrheic dermatitis.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8212685
• MDR Text Key: 132234706
• Report Number: MW5082771
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ESS305
• Device Lot Number: 787008
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR
• Patient Weight: 66